Senior QC Data Reviewer - 2nd Shift (+10% Differential)

Nitto Avecia; Milford (MA); On-site; USD 91,000 - 112,000; Full time

Benefits offered by this job

Shift differential (10%)

Job summary

Nitto Avecia in Milford, MA is seeking a Quality Data Reviewer to lead GMP data review, compile stability reports, COAs, and data summaries, and support investigations and CAPAs with QA to ensure timely release of stability batches.

This is a second shift role with a 10% shift differential; candidates should have extensive QC data experience, proficiency with HPLC, Karl Fischer, UV/Vis, and LCMS, and knowledge of ICH/CFR guidelines.

Qualifications

• BS in Chemistry or related field with 8+ years' experience or MS with 5+ years' experience
• BS/MS in chemistry, biology, or related discipline
• 8+ years' experience as a QC chemist/analyst
• Interpersonal skills to lead and train less experienced QC staff
• Experience with analytical testing equipment and methodology including HPLC, Karl Fischer, Spectrophotometry (UVNIS), LCMS
• Familiarity with ICH and CFR guidance's

Responsibilities

• Review quality data and reports for compliance against specifications and GMP regulations
• Author stability reports, COAs, data summaries, SOPs, and investigation reports
• Provide training and guidance to other analysts
• Ensure safety and contribute to EHS performance

Skills

Interpersonal skills to lead and train

Attention to detail

Education

BS in Chemistry or related field

MS in Chemistry or related field

Tools

HPLC

Karl Fischer

Spectrophotometry (UV-Vis)

LCMS

Job description

Nitto Avecia in Milford, MA is seeking a Quality Data Reviewer to lead GMP data review, compile stability reports, COAs, and data summaries, and support investigations and CAPAs with QA to ensure timely release of stability batches.

This is a second shift role with a 10% shift differential; candidates should have extensive QC data experience, proficiency with HPLC, Karl Fischer, UV/Vis, and LCMS, and knowledge of ICH/CFR guidelines.